Excellence in Pharmacovigilance Model

EXCELLENCE IN PHARMACOVIGILANCE MODEL

sThe ERMS Working Group adopted an approach to establishing a European Risk Management Strategy based on the model for delivering effective pharma-covigilance known as ‘Excellence in Pharmacovigilance’. This was the result of a project set up by the then UK Medicines Control Agency and published in 2003. It is a conceptual framework for achieve-ment of demonstrable effectiveness in terms of public health protection, comprising the following components: (Figure 44.1).

•   Best evidence, moving up the ‘evidence hierarchy’ away from spontaneous ADR reports to more reliable evidence, from observational studies and clinical trials.

•   Robust decision-making, including analysis of potential impact of signals on risk–benefit balance.

‘Tools’ to protect public health including effective communication mechanisms as well as action to update the marketing authorisation.

•   Routine outcome measures and audit of regulatory action.

•   A culture of scientific development which keeps pace with new developments and maximises oppor-tunities for improving pharmacovigilance offered by new scientific and technological advances.

The so-called ‘Excellence’ model not only defined the prerequisites for an effective pharmacovigilance system, but argued for a change in mindset, a shift from searching for evidence of harm to demonstrating safety, and a capability to demonstrate that serious adverse reactions are rare in the long term. This in turn requires a consideration at the time of licensing a new medicine of the level of safety already demonstrated, any possible concerns which need further investi-gation and appropriate strategies by which further evidence is to be gathered.

This proactive approach to demonstrating safety merited wider debate, and the International Confer-ence on Harmonisation presented an opportunity to gain the perspective of the United States and Japan. The outcome was the harmonised tripartite guide-lines E2E on Pharmacovigilance Planning, adopted in November 2004. This guideline sets out the elements of the safety specification and provides guidance on the structure of the pharmacovigilance plan and appropriate methodologies to generate information on known risks as well as what is not known.